Associate Director, RA CMC
Associate Director, RA CMC
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Job Description
extranotordinary
Position Summary:
The position is responsible for all the operational matters related to RA CMC activities in designated project under the supervision of the Head of RA CMC Japan. As the nature of Genmab KK start-up phase this position covers not only RA CMC-related activities but also helps support various operational matters for Regulatory Affairs & QA functions.
Responsibilities will include but are not limited to;
Make a strategic J-NDA plan for RA CMC and execute;
Deeply understand CMC requirements for J-NDA and evaluate the global CTD and conduct gap analysis.
Plan & execute CMC-related CTD preparation collaborating with QA and RA colleagues to keep J-NDA timeline.
Decide J-CTD policy related to CMC draft J-CTD with global colleagues and realize high-quality J-CTD.
Respond to Health Authorities inquiries interacting with global colleagues.
Select and manage 3rd vendors related to CMC in order to ensure robust CMC activities.
Support & execute QA/RA activities if required.
Execute post-approval lifecycle management;
Evaluate the changes/deviations of manufacturing/analytical procedure which may affect approval matters for MCN/PCA.
Plan the MCN/PCA schedule and share it with QA/RA/global colleagues. Lead regulatory activity related to the change.
Manage appropriate CTD lifecycle and ensure the consistency between Master Batch Record/SOP CTD (m3 and m2.3) and approval matter (m1.2).
Grasp the latest domestic and overseas technologies and regulations;
Strive for self-improvement through industrial seminar and activities and always maintain the latest knowledge.
Use the acquired knowledge and information (trends of other companies etc.) in business.
Depth understanding of Manufacturing/Testing methods prepare high-quality CTD;
Understand the details of the actual manufacturing process and analytical procedures and create a CTD that is consistent with batch records and SOPs.
Be involved in project team meetings;
Understand the background of the product/formulation development and grasp its development schedule.
Sharing information with global teams when there are RA CMC-related requirements specific to Japan.
Requirements
- More than a bachelors degree a pharmacist license is preferable.
- At least 5 years of pharmaceutical industry experience in RA CMC either in RA and/or QA.
- At least 3 years of bio/synthesis/analytical/formulation laboratory and/or manufacturing experience.
- Experience in preparing M1.2 and 2.3 (biological products) based on Global M3 Batch record SOP Validation report and Stability report.
- English (business level)
25Tbispecific T-cell engagersADC
2030
1999
Required Experience:
Director
Employment Type
Full-Time
